Virtual Reality and D-Cycloserine in Combat Related Psycological Trauma in Burn Service Members - Full Text View

Sponsored by:	United States Army Institute of Surgical Research
Information provided by:	United States Army Institute of Surgical Research
ClinicalTrials.gov Identifier:	NCT00855153

Purpose

The purpose of this pilot study is to begin the examination of the feasibility of using Gradual Virtual Reality Exposure Therapy and D-Cycloserine (DCS) in the management of posttraumatic psychological symptoms in burned OIF/OEF military combatants. The purpose of a feasibility study is to determine if there is clinical utility in this proposed treatment and to establish effective and safe treatment procedures. Given current literature, the following hypotheses are generated: Hypothesis 1: Virtual Reality Exposure and D-Cycloserine medication (VRE + DCS learning pill) will result in clinically meaningful PTSD symptom reduction.

SMs will attain scores that are lower than initial measures for symptoms of PTSD
By the completion of VRE, Ss will attain scores in the sub-clinical range for measures of clinical depression Hypothesis 2: SMs will report greater life satisfaction following completion of VR+DCS treatment, as measured by scores on the Quality of Life Inventory (QOLI) when compared to pre-treatment scores

Condition	Intervention
Psychological Trauma	Other: VR (Virtual reality) Drug: D-Cycloserine

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Efficacy Study
Official Title:	A Pilot Study Using Gradual Virtual Reality Exposure Therapy and D-Cycloserine (DCS) for Treatment of Combat Related Psychological Trauma in Burn Service Members

Resource links provided by NLM:

MedlinePlus related topics: Burns Injuries Wounds

Drug Information available for: Cycloserine

U.S. FDA Resources

Further study details as provided by United States Army Institute of Surgical Research:

Primary Outcome Measures:

Reduction in PTSD symptoms for burn patients and improve perceived life satifaction. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	4
Study Start Date:	April 2009
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
treatment: Experimental Subjects receive 50mg DCS prior to 90 min session with graded VRE treatment	Other: VR (Virtual reality) VR stimulation of combat scenarios utilized as the exposure therapy tool. Drug: D-Cycloserine 50 mg DCS 30 min prior to individual 90 min session with graded VR exposure treatment

Detailed Description:

The purpose of this study is to establish systematic observations about the feasibility of using gradual exposure virtual reality treatment and D-Cycloserine (VRE + DCS) with service members receiving medical care for burns attained during combat. The rational for this study comes from the need to establish with this population, when and how VRE + DCS might be delivered in a safe and systematic fashion. This would be done in preparation for the potential of a future controlled study to address the efficacy of VRE + DCS in comparison to each component and control group.

This study seeks to establish methods of applying VRE + DCS in relation to medical viability as an attempt to clarify at what stage of medical care a service member is able to give informed consent, follow the proscribed instructions, and participate in VRE+ DCS process to include reasonable attention and capacity for immersion.

Other areas that will be examined include medication suitability, expected course of medical treatment that would allow for reasonable completion of twelve sessions within twenty weeks, and assessed stability in social support.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

You are an active duty military male or female service member 18-45 years old and able to participate for duration of care (estimated 12 weeks for initial examination to completion of treatment)
You have a diagnosis of Post Traumatic Stress Disorder (PTSD) based on a structured clinical interview
You have a score of greater than 40 on the Clinician Administered PTSD Scale (CAPS)

Exclusion Criteria:

Psychotic disorders such as schizophrenia, bipolar affective disorder, or history of disruptive non-compliant behaviors
Borderline intellectual functioning and attention memory problems as identified by standard USAISR neuropsychological screenings;
Major neurological or major medical difficulties, to include epilepsy/seizures or significant cardiovascular conditions such as heart or blood problems that would be dysregulated by increased anxiety exposure;
Dependent on drugs based upon screening, self-report or medical record;
Motion sickness as seen on the VR assessment trial.
Subjects screened with CAPS scores 44 or lower at pre-treatment assessment.
Women who are pregnant or breast feeding.
Unhealed uncovered wounds on face that would be a significant discomfort or infection risk
Open uncovered wound to hands or face that the doctor sees at being a moderate or greater risk for treatment complications.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00855153

Contacts

Contact: Kathryn Gaylord, RN, PhD	210-916-3527	kathryn.gaylord@amedd.army.mil
Contact: Annette McClinton, RN, M A	210-916-2834	annette.mcclinton@amedd.army.mil

Locations

United States, Texas
US Army Institute of Surgical Research
Ft Sam Houston, Texas, United States, 78234

Sponsors and Collaborators

United States Army Institute of Surgical Research

Investigators

Principal Investigator:

Kathryn M Gaylord, RN, PhD

US Army Institute of Surgical Research

More Information

Publications:

Davis M, Ressler K, Rothbaum BO, Richardson R. Effects of D-cycloserine on extinction: translation from preclinical to clinical work. Biol Psychiatry. 2006 Aug 15;60(4):369-75. Review.

Responsible Party:	US Army Institute of Surgical Research ( Kathryn Gaylord )
Study ID Numbers:	H-09-012
Study First Received:	March 3, 2009
Last Updated:	March 3, 2009
ClinicalTrials.gov Identifier:	NCT00855153 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by United States Army Institute of Surgical Research:

PTSD
burns
virtual reality exposure
D-Cycloserine
Combat related psychological trauma in burned servicemembers

Study placed in the following topic categories:

Antimetabolites
Cycloserine
Burns
Anti-Bacterial Agents
Anti-Infective Agents

Wounds and Injuries
Disorders of Environmental Origin
Anti-Infective Agents, Urinary
Antitubercular Agents

Additional relevant MeSH terms:

Cycloserine
Antimetabolites
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Wounds and Injuries
Disorders of Environmental Origin
Anti-Infective Agents, Urinary

Renal Agents
Pharmacologic Actions
Antibiotics, Antitubercular
Anti-Bacterial Agents
Therapeutic Uses
Antitubercular Agents

ClinicalTrials.gov processed this record on September 11, 2009